JP2013524884A - Catheter device - Google Patents

Abstract

  The catheter device (10) includes a catheter (12) and a catheter hub (14) having a distal portion and a proximal portion, the distal portion coupled to the catheter and the proximal portion defining a cavity (24). A needle (16) extending through the catheter hub and catheter, defining an axial direction, having opposite proximal and distal ends, the distal end forming a needle tip (18) ), A needle base (20) attached to the proximal end of the needle, and a needle guard (26) slidably attached around the needle, the needle guard comprising a catheter hub and a catheter. The needle guard is retained in the cavity of the catheter hub when extending through the needle and the needle guard can be removed from the catheter hub when the needle tip is received in the needle guard when the needle is withdrawn from the catheter. it can.

Description

  The present invention relates to a catheter device, the device having a catheter, a distal portion and a proximal portion, the distal portion being connected to the catheter and the proximal portion defining a cavity, and the catheter hub and the catheter A needle extending through and defining an axial direction, having opposite proximal and distal ends, the distal end forming a needle tip, and attached to the proximal end of the needle A needle base and a needle guard slidably mounted about the needle, wherein the needle guard is within the catheter hub cavity when the needle extends through the catheter hub and the catheter. The needle guard can be removed from the catheter hub when the needle tip is received within the needle guard when the needle is withdrawn from the catheter.

  As used herein, the term proximal refers to the location of the instrument closest to the clinician using the instrument, for example. Conversely, the term distal refers to the distal needle tip of the instrument that will be inserted into the furthest position from the clinician, eg, into the patient's vein.

  The above types of catheter devices are generally known and are typically used to facilitate insertion and placement of a catheter or other medical device into a patient.

  Clinicians and other healthcare professionals who handle catheters due to increased incidence of infections caused by blood-borne pathogens such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) Or personnel need to be protected from accidental contact with the sharp needle tip after removal of the needle from the catheter and catheter hub.

  An object of the present invention is to provide a catheter device that can be manufactured at low cost and that reliably protects against a needle stick accident after the needle has been removed from the catheter and catheter hub.

  The above object is achieved by a catheter device having the features of claim 1.

  The catheter device of the present invention includes a catheter, a catheter hub having a distal portion and a proximal portion, the distal portion being connected to the catheter, and the proximal portion defining a cavity, and passing through the catheter hub and the catheter. A needle extending and defining an axial direction, having opposite proximal and distal ends, the distal end forming a needle tip, and a needle base attached to the proximal end of the needle; A needle guard slidably mounted about the needle, the needle guard engaging the outside of the catheter when the needle extends through the catheter hub and catheter Is held in the cavity of the catheter hub, and the needle guard can be removed from the catheter hub when the needle tip is received in the needle guard when the needle is withdrawn from the catheter.

  The needle guard functions as a protection against the needle tip by automatically covering the needle tip while the needle is being removed from the catheter. Therefore, the needle guard is useful for preventing a needle stick accident of a clinician or the like by the needle tip after removing the needle from the catheter.

  Securing the needle guard within the catheter hub cavity by a retaining arm that engages the outside of the catheter hub allows the needle guard to be safely seated within the catheter hub cavity so that the needle guard does not receive the needle tip. A simple means to effectively prevent accidental detachment from the catheter cavity. Therefore, the catheter device of the present invention can be manufactured at a low cost, and at the same time, improves the safety of the catheter device.

  According to the invention, the proximal end of the holding arm is connected to the base of the needle guard by means of a transverse part. The transverse portion may extend generally radially, i.e. perpendicular to the axial direction defined by the needle. Preferably, the transverse portion extends from the proximal end region of the needle guard.

  According to another embodiment, the holding arm extends in a direction that is not parallel to the axial direction. For example, the retention arm may form an angle, particularly in the range of 0 ° to 10 ° with the axial direction, so that the spacing between the retention arm and the catheter hub decreases toward the distal end of the retention arm. Good. By thus orienting the holding arm diagonally, the holding arm can easily function as a spring-type arm, and as a result, the holding effect of the holding arm is enhanced.

  In order to further increase the holding effect of the holding arm, a hook-like protrusion may be provided in the region of the distal end of the holding arm.

  The holding effect is achieved by providing protrusions or depressions or a combination of protrusions and depressions on the outer surface of the catheter and engaging with the holding arm, in particular with hook-like protrusions provided in the region of the distal end of the holding arm. If so, it can be further enhanced.

  According to another embodiment, at least one support arm for engaging the outer surface of the catheter hub is located on the side of the needle guard opposite the holding arm. The support arm helps to prevent the needle guard received by the catheter hub from moving radially within the cavity. In other words, the support arm stabilizes the needle guard within the catheter hub, thus further positioning the needle guard at a desired position within the cavity. The support arm may or may not be in a holding relationship with the catheter hub.

  According to yet another embodiment, the needle guard comprises, in the region of its proximal end, a generally cylindrical base and first and second arms extending generally axially from the distal side of the base, The first and second arms are wound with tension elements, such as elastic bands, in the distal regions of the first and second arms.

  The tensioning element is used when the first and second arms are open to each other by a needle that fully penetrates the needle guard, as is typical when the catheter is stored prior to use. Apply resilience to the second arm. Therefore, even after being stored for a longer time than usual, the tension elements ensure that the mutually open arms snap together to guard the needle tip when the needle is removed from the catheter. Therefore, the correct function of the needle guard is continuously ensured. In addition, the tensioning element prevents the arm from loosening when the needle safety device slides along the needle, thus further functioning the needle safety device correctly. Moreover, the tension element helps to prevent the needle tip from jumping sideways out of the needle guard, thereby further enhancing the protective function of the needle safety device.

  Preferably, the first and second arms are opened to each other by the needle completely penetrating the needle guard, keeping the tension element engaged with the inner surface of the catheter hub. This increases the holding effect provided by the holding arm and further improves the safety of the device. The inner surface of the catheter hub, particularly the inner surface that defines the cavity, may be generally smooth.

  A lateral wall may be placed in the distal region of one of the first and second arms to prevent the needle tip received in the needle guard from popping distally out of the needle guard. A groove is formed in the side surface of the lateral wall, and the groove extends substantially in the axial direction. The groove serves as a needle guide groove and helps the needle move axially with respect to the needle guard. In addition, the needle should not be displaced laterally from the lateral wall. This lateral movement requires a stronger force to move the needle with respect to the needle guard, which hinders the correct functioning of the needle guard.

  According to another embodiment, a recess is formed in the one of the first and second arms, that is, the arm provided with the lateral wall. Preferably, the recess is formed on the outside of the arm and / or in the region between the base and the tension element. The recess makes it easier for the arm to bend in the area where it is formed, thus reducing the restoring force on the lateral wall while it is supported by the needle. As a result, the frictional force applied to the needle is reduced, making it easier to move the needle with respect to the lateral wall. The recess may be formed by a groove extending in a direction crossing both the axial direction and the radial direction, for example.

  The manufacturing cost of the catheter device is particularly low if the base, the first and second arms, the holding arm, and the support arm are integrally made of the first material. The first material may be a plastic material, for example. Therefore, the base, the first and second arms, the holding arm, and the support arm can be manufactured by injection molding.

  Alternatively, the base, one of the first and second arms, and the holding arm can be integrally made of a first material, such as a plastic material, and the other of the first and second arms is different from the first material. It can be made of a second material. For example, the other of the first and second arms can include a strip of material having spring-like characteristics, such as a sheet metal strip.

  According to another embodiment, the base of the needle guard has an axial hole for receiving the needle extending therein, the shape of the hole being adapted to the main outer diameter shape of the needle, the needle being a needle A shape changing portion, particularly an enlarged portion, is provided near the tip, and the outer shape of the shape changing portion is partly larger than the maximum size of the hole shape. The shape changing portion prevents the needle guard from slipping out of the needle when the needle tip is received between the arms, and as a result, the protection function of the needle safety device is further improved.

  The shape changing portion may be provided by caulking a needle, for example. However, it is also possible to provide the shape change portion by other methods. For example, there is a method of intensively heating a local region of the needle using a welding process such as a laser welding process without adding another material. is there. Alternatively, the shape changing portion may be formed by applying another material to the outer surface of the needle. In order to position the applied material in place, a recess or groove may be formed on or around the outer surface of the needle. Another material may be selected from at least one of, for example, a plastic material, an adhesive, a resin, and a metal material.

  When the other material is a metal material, the shape change portion may be formed by, for example, welding another material on the surface of the needle or soldering. Alternatively, another material can be attached to the needle with an adhesive.

  The inner diameter shape of the needle can be reduced in the region of the shape change portion, for example, when the shape change portion is formed by caulking, or the shape change is formed, for example, by attaching another material to the needle. In some cases, it can be substantially constant throughout the length of the needle.

  According to yet another embodiment, the base of the needle guard is made of a first material and has an axial hole for receiving the needle extending therein, the base or its distal or proximal end. The stopper element is installed in a second material different from the first material and has a through-hole shaped concentrically with the axial hole and adapted to the main outer diameter shape of the needle The needle has a shape changing portion in the vicinity of the needle tip, and the outer diameter shape of the shape changing portion is larger than the maximum size of the hole shape.

  Preferably, the second material has a higher hardness and / or stiffness than the first material. For example, the first material can be a plastic material and the second material can be comprised of a metal, ceramic or rubber material, or other type of material that is hard and not as easily deformed as the first material. .

  Furthermore, the stopper element can be a circular disc, a ring or a washer. However, it need not be circular, but can be other geometric shapes such as a rectangle, square or triangle.

  Alternatively, the stopper element may be formed by one of the first and second arms, in particular from the proximal end of the arm, which arm is preferably formed from a sheet metal strip. This embodiment is particularly advantageous, not only because the arm serves a dual function and prevents the needle tip from popping distally out of the needle guard, but the needle guard continues to slide. Because it helps to keep it from coming off.

It is a side view of the catheter apparatus of this invention before use. It is a side view of the catheter apparatus of this invention before use. It is a side view of the needle guard which protects the needle after use of the catheter apparatus of FIG. 1, the needle base attached thereto, and the tip of the needle. It is a perspective view of the needle guard of FIG. It is a perspective view of the needle guard of FIG. It is a side view of the needle guard of FIG. 2 is a longitudinal side view of a needle guard received in a catheter hub of the catheter device of FIG. It is a side view of another needle guard. It is a perspective view of another needle guard. FIG. 6 is a side view of the needle guard of FIG. 5 without a tension element. FIG. 6 is a perspective view of the needle guard of FIG. 5 without a tension element. FIG. 6 is a longitudinal sectional view of the needle guard of FIG. 5 without a tension element.

  Preferred embodiments of the invention are shown in the following description and the accompanying drawings.

  FIG. 1 shows a catheter device 10 according to the invention prior to use. The catheter device 10 has a tubular catheter 12 having a distal end and a proximal end, and a catheter hub 14 attached to the catheter 12 at the proximal end of the catheter.

  Catheter device 10 further includes a needle 16 extending through catheter 12 and catheter hub 14 and defining an axial direction. The needle 16 has a distal end and a proximal end, and a sharp needle tip 18 is formed at the distal end of the needle 16 that protrudes from the catheter 12 at its distal end.

  Needle base 20 is attached to needle 16 at the proximal end of needle 16. The port member 22 is attached to the needle base 20 on the proximal side of the needle base 20 so that, for example, a PCV tube is connected to the catheter device 10 to draw blood from the patient or to deliver fluid to be administered to the patient. Can be delivered.

  The catheter 14 defines an inner cavity 24 (FIG. 4) in which the needle guard 26 is seated. In FIG. 1, only the holding arm 54 of the needle guard 26 is visible. A needle guard 26 is slidably disposed around the needle 16 and moves along the needle 16 as the needle 16 is withdrawn from the catheter 12. The purpose of the needle guard 26 is to prevent a needle stick accident by the needle 16 of the person who covers the needle tip 18 and handles the catheter device 10, as can be seen from FIG.

  As shown in FIG. 3, the needle guard 26 includes a generally cylindrical base 28 at the proximal end of the needle guard 26. The first and second arms 30, 32 extend generally axially from the distal surface 34 of the base 28. The first arm 30 is longer than the second arm 32.

  A lateral wall 36 is disposed in the distal region of the first arm 30. The dimension of the lateral wall 36 when viewed in the radial direction is such that when the needle tip 18 is received in the needle guard 26, ie between the first and second arms 30, 32, the lateral wall 36 is the second arm. 32 is selected to prevent needle tip 18 from projecting distally from needle guard 26 by lateral wall 36 (FIG. 2).

  Prior to use, i.e., when the needle 16 has completely penetrated the needle guard 26, the lateral wall 36 is supported against the needle 16, and the first arm 30 is deflected away from the second arm 32. . The lateral wall 36 is formed with an axial groove 38 in its surface 40 facing the needle 16 so that the needle 16 is pulled through the needle guard 26, particularly when the needle 16 is withdrawn from the catheter 12. The lateral wall is guided around the needle 16.

  A recess 42 is formed on the outer surface of the proximal portion 44 of the first arm 30 to increase the flexibility of the first arm 30.

  The distal portions 46, 47 of the first and second arms 30, 32 have outer surfaces that taper toward the distal ends of the first and second arms 30, 32. The first and second arms 30 and 32 are wound with an elastic band 48 in the region of the distal portions 46 and 47. Since the outer surfaces of the distal portions 46 and 47 are tapered, the first and second arms 30 and 32 are mutually opposed against the restoring force of the elastic band 48 by the needle 16 that completely penetrates the needle guard 26. When open, the elastic band 48 does not slide off from the distal portions 46, 47 in the direction of the proximal end of the needle guard 26. In order to further define the axial position of the elastic band 48, a protrusion 50 extending along the outer circumference of the first and second arms 30, 32 can be provided in the vicinity of the elastic band 48 (FIG. 4). These protrusions 50 are not shown in FIGS.

  As best seen in FIG. 4, an axial bore 52 extends through the base 28 of the needle guard 27 for receiving the needle 16. The shape of the hole 52 is adapted to the main outer diameter shape of the needle 16. The needle 16 has a shape change portion, particularly an enlarged portion (not shown), in the vicinity of the needle tip 18, and the size of one part of the outer diameter shape is larger than the maximum size of the shape of the hole 52. Therefore, when the needle tip 18 is received between the first and second arms 30 and 32 by the shape changing portion and covered with the needle guard 26, the needle guard 26 does not slide out of the needle 16.

  A retaining arm 54 is placed on the needle guard 26 so that the needle guard 26 is secured within the catheter hub cavity 24 so that the needle tip 18 is safely received within the needle guard 26, particularly when the needle 16 is withdrawn. The needle guard 26 cannot be removed from the catheter hub 14 before long. The holding arm 54 is connected to the base 28 of the needle guard 26 via a crossing 56. The transverse portion 56 extends generally radially outward from the base 28 on the side of the second arm 32. The holding arm 54 extends distally from the lateral portion 56 and is slightly inclined toward the second arm 32. Preferably, the holding arm 54 makes an angle in the range of 0 ° to 10 ° with the axial direction so that the gap between the holding arm 54 and the second arm 32 is towards the distal end of the holding arm 54. Narrow.

  A hook-like protrusion 58 is installed in the region of the distal end of the holding arm 54. The hook-like protrusion 58 of the holding arm 54 fits into a groove or recess 61 provided on the outer surface 62 of the catheter hub 14 and behind the corresponding protrusion 60. Due to the combination of the hook-like protrusion 58 of the holding arm 54 and the convex portion 60 and concave portion 61 formed on the catheter hub 14, the needle guard 26 cannot move in the axial direction with respect to the catheter hub 24, and when the needle 16 is pulled out of the catheter 12. The catheter hub 14 until the pulling force applied to the base 28 of the needle guard 26 through the shape change of the needle 16 from the needle 16 is sufficiently large and the holding arm 54 is disengaged from the convex portion 60 of the catheter hub 14. Effectively retained.

  It should be noted that, instead of forming a combination of the convex portion 60 and the concave portion 61 on the catheter hub 14, the outer surface 62 of the catheter hub 14 is provided with a convex portion 60 for engaging with the hook-like protrusion 58 of the holding arm 54 or It is possible to provide any one of the recesses 61.

  If the elastic band 48 engages the inner surface 64 of the catheter hub 14 with the first and second arms 30 and 32 open from each other, the needle guard 26 is better retained in the catheter hub 14. As the needle tip 18 passes through the lateral wall 36 and the first and second arms 30, 32 snap together, thereby causing the elastic band 48 to contract, the elastic band 48 disengages from the inner surface 64 of the catheter hub 14.

  A support arm 66 is installed on the side opposite to the holding arm 54 of the needle guard 26. The support arm 66 is generally perpendicular to a transverse portion 68 that extends generally radially from the base 28. The support arm 66 is configured to contact the outer surface 62 of the catheter hub 14 generally throughout its length and width. Therefore, the support arm 66 prevents the needle guard 26 received in the catheter hub 14 from moving radially within the cavity 24. The support arm 66 also serves to secure the needle guard 26 from axial movement with respect to the catheter hub 14 so that the needle guard 26 is retained on the catheter hub 14. However, the support arm 66 does not necessarily have to be in such a holding relationship with the catheter hub 14.

  In this embodiment, the holding arm 54 is installed on the side of the base 28 near the second arm 32, and the support arm 66 is installed on the side of the base 28 near the first arm 30. However, it is also possible to install the holding arm 54 on the side close to the first arm 30 of the base 28 and the support arm 66 on the side close to the second arm 32 of the base 28.

  As shown in FIGS. 1 to 4, the base 28, the first and second arms 30 and 32, the holding arm 54, and the support arm 66 are integrally formed from, for example, a plastic material by injection molding. However, it should be understood that this integral design is not essential. Alternatively, one or more of the above components may be made of a material that is different from the material of the other components, and the component is attached to the other component, for example by adhesive, welding, soldering, etc. It may be attached.

  Although not shown in FIGS. 1-4, a stopper element may be formed in the base 28 or in the distal surface 34 of the base 28, the stopper element being connected to the axial hole 52 of the base 28. Concentric and has a through hole shaped to match the main outer diameter of the needle 16. Preferably, such a stopper element is made of a material that is harder and / or more rigid than the material of the base 28, which stopper element is applied by the shape changer of the needle 16 when the needle 16 is withdrawn from the catheter 12. The needle guard 26 is more effectively prevented from sliding off the needle 16 to withstand a force greater than the force and thereby more effectively prevent the shape change portion of the needle 16 from passing through the base 28.

  5 and 6 illustrate another needle guard 26 that can be used with the catheter device 10 of the present invention. The needle guard 26 is generally the same in function as the needle guard 26 described above, but mainly has no support arm, and the first arm 30 is integrated with the base 28, the second arm 32, and the holding arm 54. It is different in that it is not formed.

  The first arm 30 is made of a strip of sheet metal 70, its distal end 72 is bent to form the transverse wall 36, and its proximal end 74 is on the proximal face 76 of the base 28, for example Installed by gluing or welding. As described above, the elastic band 48 is provided at the distal portions 46 and 47 of the first and second arms 30 and 32, and the first and second arms 30 and 32 are opposed to each other against the restoring force of the elastic band 48. Wrapped in a state that can be opened (Fig. 5)

  As best seen in FIG. 6C, a through hole 78 is provided at the proximal end of the strip of sheet metal 70, which is concentric with the axial hole 52 in the base 28. The shape of the through-hole 78 is adapted to the main outer diameter shape of the needle 16, whereas the shape of the axial hole 52 is somewhat wider. Therefore, in the needle guard 26, the shape change portion, for example, the enlarged portion, of the needle 16 can slide along the axial hole 52, and its movement in the proximal direction is caused by the sheet on the proximal side of the base portion 28. Limited only when engaged with the proximal end 74 of the strip of metal 70. The proximal end 74 of the strip of sheet metal 70 therefore functions as a stop element of the type described above and helps to prevent the needle guard 26 from sliding off the needle 16.

  Further, as a difference from the needle guard 26 shown in FIGS. 1 to 4, in the case of the needle guard 26 of FIGS. 5 and 6, an axial groove 38 for guiding the needle 16 when moving with respect to the needle guard 26. Is formed on the second arm 32 rather than on the first arm 30, which is best seen in FIG. 6B.

  10 catheter device, 12 catheter, 14 catheter hub, 16 needle, 18 needle tip, 20 needle base, 22 port member, 24 cavity, 26 needle guard, 28 base, 30 first arm, 32 second arm, 34 far Lateral surface, 36 transverse wall, 38 axial groove, 40 side surface, 42 recess, 44 proximal portion, 46 distal portion, 47 distal portion, 48 elastic band, 50,58 protrusion, 52 axial hole, 54 holding Arm, 56 Transverse, 60 Convex, 61 Concave, 62 Outer, 64 Inner, 66 Support Arm, 68 Transverse, 70 Sheet Metal Strip, 72 Distal End, 74 Proximal End, 76 Proximal Surface, 78 Through hole.

Claims (22)

In the catheter device (10),
A catheter (12);
A catheter hub (14) having a distal portion and a proximal portion, wherein the distal portion is coupled to the catheter (12) and the proximal portion defines a cavity (24); ,
A needle (16) extending through and defining an axial direction through the catheter hub (14) and the catheter (12), having a proximal end and a distal end opposite to each other; A needle (16) whose distal end forms a needle tip (18);
A needle base (20) attached to the proximal end of the needle (16);
A needle guard (26) slidably mounted around the needle (16), the needle (12) extending through the catheter hub (14) and the catheter (12). Is held in the cavity (24) of the catheter hub (14) by a holding arm (54) that engages the outside of the catheter hub (14), and the needle (16) is held in the catheter (12). A needle guard (26) that can be removed from the catheter hub (14) when the needle tip (18) is received in the needle guard (26) when removed from the catheter hub (14);
A catheter device (10) comprising: The catheter device (10) according to claim 1,
The proximal end of the retaining arm (54) is connected to the base of the needle guard (26) by a cross section (56), in particular the cross section (56) is generally radially and / or the needle guard. Catheter device (10), characterized in that it extends from the proximal end region of (26). The catheter device (10) according to claim 1 or 2,
The holding arm (54) extends non-parallel to the axial direction, and in particular forms an angle in the range of 0 ° to 10 ° with the axial direction, in particular between the holding arm (54) and the catheter hub (14). The catheter device (10), characterized in that the gap of the catheter narrows towards the distal end of the holding arm (54). The catheter device (10) according to any one of claims 1 to 3,
A catheter device (10) characterized in that a hook-like projection (58) is provided in the region of the distal end of the holding arm (54). The catheter device (10) according to any one of claims 1 to 4,
On the outer surface (62) of the catheter hub (14) there is a protrusion (60) or a recess or a combination of protrusion and recess in the holding arm (54) and in particular in the region of the distal end of the holding arm (54). A catheter device (10) characterized in that it is provided to engage with a hook-like projection (58) installed. The catheter device (10) according to any one of claims 1 to 5,
At least one support arm (66) for engaging the outer surface (62) of the catheter hub (14) is provided on the surface of the needle guard (26) opposite the holding arm (54). A catheter device (10), characterized in that The catheter device (10) according to any one of claims 1 to 6,
The needle guard (26) has a generally cylindrical base (28) in the region of its proximal end and first and second arms (30, 30) extending generally axially from the distal side of the base (28). 32), and the first and second arms (30, 32) are wound with a tension element, for example an elastic band (48), in the distal region of the first and second arms. A catheter device (10) characterized by: The catheter device (10) according to claim 7,
The first and second arms (30, 32) are opened to each other by the needle (16) extending completely through the needle guard (26), and the tension element (48) is connected to the catheter hub ( 14) A catheter device (10), characterized in that it is held in engagement with the inner surface (64) of 14). Catheter device (10) according to claim 7 or 8,
A lateral wall (36) is disposed in one distal region of the first and second arms (30, 32), and a groove (38) is provided on a side surface (40) of the lateral wall (36), and the groove ( Catheter device (10) characterized in that 38) extends generally axially. The catheter device (10) according to any one of claims 7 to 9,
A recess (42) is formed on the one of the first and second arms (30, 32), particularly on the outside of the arm and / or in the region between the base (28) and the tension element (48). Preferably, the catheter (10) is characterized in that the recess (42) is formed by a groove extending in a direction transverse to both the axial and radial directions. The catheter device (10) according to any one of claims 7 to 10,
The base (28), the first and second arms (30, 32), the holding arm (54) and, if present, the support arm (66) are made from a first material, eg a plastic material, eg injection. A cartel device (10), which is integrally formed by molding. The catheter device (10) according to any one of claims 7 to 10,
The base (28), one of the first and second arms (30, 32), and the holding arm (54) are integrally made from a first material, eg, a plastic material, and the first and second Catheter device (10), characterized in that the other of the arms (30, 32) is made of a second material different from the first material. The catheter device according to claim 12,
Catheter device (10) characterized in that said other of said first and second arms (30, 32) comprises a strip of material having spring-like properties, for example a strip of sheet metal. The catheter device (10) according to any one of claims 7 to 13,
The base (28) of the needle guard (26) has an axial hole (52) for receiving the needle (16) extending therethrough, the shape of the hole (52) being It is adapted to the main outer diameter shape of the needle (16), the needle (16) has a shape changing portion in the vicinity of the needle tip (18), and the size of one part of the outer diameter shape of the shape changing portion is Catheter device (10) characterized in that it is larger than the maximum dimension of the shape of the hole (52). The catheter device (10) according to any one of claims 7 to 13,
The base (28) of the needle guard (26) is made of a first material and has an axial hole (52) for receiving the needle (16) extending therethrough, the stopper element being Provided on the base (28) or distal or proximal thereof, the stopper element is made of a second material different from the first material and is concentric with the axial hole (52); The needle (16) has a through hole having a shape adapted to the main outer diameter shape of the needle (16), the needle (16) has a shape changing portion in the vicinity of the needle tip (18), and the shape changing portion Catheter device (10) characterized in that the dimension of the part of the outer diameter shape is larger than the maximum dimension of said shape of said hole (52). Catheter device (10) according to claim 15,
The catheter device (10), wherein the second material has higher hardness and / or stiffness than the first material. A catheter device (10) according to claim 15 or 16,
Catheter device (10), characterized in that said stopper element has a disk-like shape and / or is made as a ring or washer. A catheter device (10) according to claim 15 or 16,
Said stopper element is defined by one of said first and second arms (30, 32), in particular by the proximal end (74) of said arm (30), said arm (30) preferably being made of sheet metal. Catheter device (10) characterized in that it is formed from a strip (70). The catheter device (10) according to any one of claims 14 to 18,
The shape changing portion is formed by intensively heating a local region using a welding process such as a laser welding process, with or without another material added to the needle (16). A catheter device (10) characterized in that The catheter device (10) according to any one of claims 14 to 18,
The catheter device (10), wherein the shape changing portion is formed by applying another material to the outer surface of the needle (16). The catheter device (10) according to claim 20,
The catheter device (10), wherein the another material is selected from at least one of a plastic material, an adhesive, a resin and a metal material. The catheter device (10) according to any one of claims 1 to 21,
Catheter device (10) characterized in that the inner surface (64) of said catheter hub, in particular the inner surface (64) defining said cavity (24), is generally smooth.

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